1

How to create your

Label?
EU MDR 2017/745
MONIR EL AZZOUZI
 MEDICAL DEVICE QUALITY IS ALL WE DO,
AND WE’RE ALWAYS AHEAD OF THE GAME.

75 275k #1 114k “Great eQMS Software…”

years industry podcast listeners blog and podcast look to us for the “The software is easy to use with little to
experience in the industry latest in quality no customization needed. It has been a
great tool for developing our device
through design control. The post-market
additions have been amazing as well as
tasks. After using multiple types of
eQMS software over the years, this is
FEATURED IN the best by far!”

“My QMS is world class” “Design controls lifesaver”

“One-stop shop” “Fantastic product, even better team”

 3
Monir El Azzouzi
CEO & Founder
Easy Medical Device ► Medical Device Expert specialized in
Quality and Regulatory Affairs
► Blogger, Youtuber, Podcaster
► 15 years of experience in the Medical
Device industry within big companies
(Bbraun medical, Bausch + Lomb, Johnson
& Johnson)
► Created the consulting agency Easy
Medical Device to support Medical Device
manufacturers
► Offer UK Responsible Person service and EU
representative service

©Copyright 2021 Easy Medical Device GmbH

 4

General information

EU MDR 2017/745

©Copyright 2021 Easy Medical Device GmbH

 5
Label definition (Article 2)

► ‘label’ means the written, printed or

graphic information appearing either on
the device itself, or on the packaging of
each unit or on the packaging of multiple
devices;
► This is part of the product.

©Copyright 2021 Easy Medical Device GmbH

 6
Claims (Article 7)

In the labelling, instructions for use, making available, putting into service and advertising of
devices, it shall be prohibited to use text, names, trade marks, pictures
and ◄ figurative or other signs that may mislead the user or the patient with regard to
the device's intended purpose, safety and performance by:
► (a) ascribing functions and properties to the device which the device does not have;
► (b) creating a false impression regarding treatment or diagnosis, functions or properties
which the device does not have;
► (c) failing to inform the user or the patient of a likely risk associated with the use of the
device in line with its intended purpose;
► (d) suggesting uses for the device other than those stated to form part of the
intended purpose for which the conformity assessment was carried out.

©Copyright 2021 Easy Medical Device GmbH

 7
Manufacturer obligation (Article 10)

► 11.  Manufacturers shall ensure that the

device is accompanied by the
information set out in Section 23 of
Annex I in an official Union
language(s) determined by the
Member State in which the device is
made available to the user or patient.
The particulars on the label shall be
indelible, easily legible and clearly
comprehensible to the intended user
or patient.

©Copyright 2021 Easy Medical Device GmbH

 8
Languages (Article 10)
Country Language Country Language
Austria German France French
Belgium French and Dutch and German. Germany German, in justified case English
EPU acceptable
Bulgaria Bulgarian Greece Greek
Croatia Croatian (and English) Hungary Hungarian
Cyprus Greek (and English) Iceland Icelandic, EPU
Czech Czech Ireland English (or English and Irish)
Denmark Danish Italy Italian
Estonia Estonian Latvia Latvian
Finland Finnish and Swedish (or English) Liechtenstein German

EPU: English for professional use

©Copyright 2021 Easy Medical Device GmbH
 9
Languages (Article 10)
Country Language Country Language
Lithuania Lithuanian Slovenia Slovene
Luxembourg French or German or Spain Spanish
Luxembourgish Sweden Swedish
Malta English or Maltese Switzerland German and French and
The Netherlands Dutch, EPU Italian, EPU
Norway Norwegian Turkey Turkish
Poland Polish United Kingdom English
Portugal Portuguese
Romania Romanian
Slovakia Slovak

EPU: English for professional use

©Copyright 2021 Easy Medical Device GmbH
 10
UDI carrier on the product

Implants and Class III Class IIa and IIb Class I

UDI on device labels
Article 123.3.f and article 27.4 May 26th, 2021 May 26th, 2023 May 26th, 2025

Direct marking on reusable

devices
May 26th, 2023 May 26th, 2025 May 26th, 2027
Article 123.3.g and article 27.4

(01)09506000117843(11)141231(17)201231(10)12
34AB
(01)09506000117843(11)141231(17)201231(10)1234AB
©Copyright 2021 Easy Medical Device GmbH
 11

Start with GSPR

EU MDR 2017/745

©Copyright 2021 Easy Medical Device GmbH

 12
What is GSPR?

► General Safety and Performance

Requirements
► Annex I of the EU MDR 2017/745
► Contains 23+ requirements to fulfil
► Chapter III – Requirements regarding
the information supplier with the
device

©Copyright 2021 Easy Medical Device GmbH

 13
GSPR chapter III
23. Label and instructions for use
23.1 General requirements regarding the information supplied by the manufacturer
Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any
safety and performance information relevant to the user, or any other person, as appropriate. Such information may
appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website,
be made available and kept up to date on the website, taking into account the following:
(a) The medium, format, content, legibility, and location of the label and instructions for use shall be appropriate to the
particular device, its intended purpose and the technical knowledge, experience, education or training of the intended
user(s). In particular, instructions for use shall be written in terms readily understood by the intended user and, where
appropriate, supplemented with drawings and diagrams.
(b) The information required on the label shall be provided on the device itself. If this is not practicable or appropriate,
some or all of the information may appear on the packaging for each unit, and/or on the packaging of multiple devices.
(c) Labels shall be provided in a human-readable format and may be supplemented by machine-readable information,
such as radio-frequency identification ('RFID') or bar codes.
(h) Where appropriate, the information supplied by the manufacturer shall take the form of internationally recognised
symbols. Any symbol or identification colour used shall conform to the harmonised standards or CS. In areas for which no
harmonised standards or CS exist, the symbols and colours shall be described in the documentation supplied with the
device.
©Copyright 2021 Easy Medical Device GmbH
 14
GSPR chapter III
23.2. Information on the label. The label shall bear all of the following particulars:
23.2 (a) the name or trade name of the device;
(b) the details strictly necessary for a user to identify the device, the contents of the packaging
and, where it is not obvious for the user, the intended purpose of the device;
(c) the name, registered trade name or registered trade mark of the manufacturer and the
address of its registered place of business;
(d) if the manufacturer has its registered place of business outside the Union, the name of the
authorised representative and address of the registered place of business of the authorised
representative;
(e) where applicable, an indication that the device contains or incorporates:
– a medicinal substance, including a human blood or plasma derivative, or – tissues or cells, or
their derivatives, of human origin, or – tissues or cells of animal origin, or their derivatives, as
referred to in Regulation (EU) No 722/2012;

©Copyright 2021 Easy Medical Device GmbH

 15
GSPR chapter III

23.2. Information on the label. The label shall bear all of the following particulars:
23.2 (f) where applicable, information labelled in accordance with Section 10.4.5.; CMR
(g) the lot number or the serial number of the device preceded by the words LOT NUMBER or
SERIAL NUMBER or an equivalent symbol, as appropriate;
(h) the UDI carrier referred to in Article 27(4) and Part C of Annex VII;
(i) an unambiguous indication of the time limit for using or implanting the device safely,
expressed at least in terms of year and month, where this is relevant;
(j) where there is no indication of the date until when it may be used safely, the date of
manufacture. This date of manufacture may be included as part of the lot number or serial
number, provided the date is clearly identifiable;
(k) an indication of any special storage and/or handling condition that applies;

©Copyright 2021 Easy Medical Device GmbH

 16
GSPR chapter III
23.2. Information on the label. The label shall bear all of the following particulars:
23.2 (l) if the device is supplied sterile, an indication of its sterile state and the sterilisation method;
(m) warnings or precautions to be taken that need to be brought to the immediate attention
of the user of the device, and to any other person. This information may be kept to a minimum
in which case more detailed information shall appear in the instructions for use, taking into
account the intended users;
(n) if the device is intended for single use, an indication of that fact. A manufacturer's
indication of single use shall be consistent across the Union;
(o) if the device is a single-use device that has been reprocessed, an indication of that fact,
the number of reprocessing cycles already performed, and any limitation as regards the
number of reprocessing cycles;
(p) if the device is custom-made, the words 'custom-made device';
(q) an indication that the device is a medical device.

©Copyright 2021 Easy Medical Device GmbH

 17
GSPR chapter III

23.2. Information on the label. The label shall bear all of the following particulars:
23.2 (q) (continued) If the device is intended for clinical investigation only, the words 'exclusively
for clinical investigation';
(r) in the case of devices that are composed of substances or of combinations of substances
that are intended to be introduced into the human body via a body orifice or applied to the
skin and that are absorbed by or locally dispersed in the human body, the overall qualitative
composition of the device and quantitative information on the main constituent or
constituents responsible for achieving the principal intended action;
(s) for active implantable devices, the serial number, and for other implantable devices, the
serial number or the lot number.

©Copyright 2021 Easy Medical Device GmbH

 18

Let’s create a Label

EU MDR 2017/745

©Copyright 2021 Easy Medical Device GmbH

 19
Information
Product Dental Implant called Easy Implant made of titanium
Class IIb Medical Device CE certified by TÜV SUD
Information Reference number: 82307-012
Lot number: 1234AB
Expiry date: 31 December 2021
Warnings: Fragile, do not use if damaged, read
instruction for use, do not resterilise
Sterilization method: Steam sterilization
Storage condition: between 4°C and 30°C
Manufacturer: Easy Medical Device
EC REP: S4M Europe
UDI-DI: 09506000117843
Languages: EN – FR - DE

©Copyright 2021 Easy Medical Device GmbH

 20

What a label would look like…

without the Symbols?

©Copyright 2021 Easy Medical Device GmbH

 en: Medical Device
21
en: Catalog number
fr: Numéro de référence 82307-012
fr: Dispositif médical
de: Medizinprodukt Easy
de: Referenznummer Dental implant 3x1,5 mm Information
en: Lot Number
Implant
Implant dentaire 3x1,5 mm
Zahnimplantat 3x1,5 mm
Dental Implant called Easy Implant
fr: Numéro de lot 1234AB made of titanium
de: Chargennummer Class IIb Medical Device CE
Material: Titanium
certified by TÜV SUD
en: Use-by-date Matière : Titane
fr: Date d’expiration 2021-12-31 Material: Titan Reference number: 82307-012
de: Haltbarkeitsdatum
en: Caution! Read the instruction for use en: Temperature limit between 4°C and 30°C Lot number: 1234AB
en: Don’t open if broken
fr: Ne pas ouvrir si endommagé fr: Attention! Lire la notice d’utilisation fr: Température limite entre 4°C et 30°C
de: Achtung! Lesen sie die Gebrauchsanweisung de: Temperaturgrenze zwischen 4°C und 30°C. Expiry date: 31 December 2021
de: Nicht öffnen, wenn es beshädigt ist
Warnings: Fragile, do not use if
en: Steam Sterilization en: Don’t resterilize en: Fragile handle with care
damaged, read instruction for use,
fr: Stérilisation à la vapeur d’eau fr: Ne pas restériliser fr: Fragile, manipuler avec soin
do not resterilise
de: Dampf steril de: Nicht erneut sterilisieren de: Zerbrechlich - Vorsichtig behandeln
0123 Steam sterilization
en: Authorized Representative in the S4M Europe
en: Manufacturer Easy Medical Device GmbH European Community
Storage condition: between 4°C
fr: Fabricant 125 Deansgate, Manchester, fr: Mandataire Europeen
59 rue Castellion, and 30°C
de: Hersteller UK M3 2LH de: Europäischer Vertreter 01100 Oyonnax - France Manufacturer: Easy Medical Device

en: UDI en: Additional information

EC REP: S4M Europe
(01)09506000117843(11)141231(17)201
fr: IUD fr: Information supplémentaire
de: Zusätzliche Information
de: UDI
231(10)1234AB Easymedicaldevice.com
UDI-DI: 09506000117843
(01)09506000117843(17)211231(10)1234AB
Languages: EN – FR - DE
©Copyright 2021 Easy Medical Device GmbH
 22
Use of symbols

► Medtech Europe:
https://www.medtecheurope.org/resource-library/use-of-symbols-to-indica
te-compliance-with-the-mdr/
► BSI Presentation:
https://www.bsigroup.com/globalassets/meddev/localfiles/it-it/webinars/b
si-md-symbols-and-information-to-be-provided-by-the-manufacturer-webin
ar.pdf
► GSPR 23.1
► (h) Where appropriate, the information supplied by the manufacturer shall take
the form of internationally recognised symbols. Any symbol or identification
colour used shall conform to the harmonised standards or CS. In areas for which
no harmonised standards or CS exist, the symbols and colours shall be
described in the documentation supplied with the device.

©Copyright 2021 Easy Medical Device GmbH

 23

Symbols ISO
15223-1

Have a legend on your IFUs

as not everyone understand
all the symbols

©Copyright 2021 Easy Medical Device GmbH

 24

What if we place
Symbols Now?

©Copyright 2021 Easy Medical Device GmbH

 25
82307-012 Easy Information
En: Dental implant 3x1,5 mm
Implant
Fr: Implant dentaire 3x1,5 mm
De: Zahnimplantat 3x1,5 mm
Dental Implant called Easy Implant
made of titanium
1234AB Class IIb Medical Device CE
certified by TÜV SUD
En: Material: Titanium
Fr: Matière : Titane Reference number: 82307-012
2021-12-31 De: Material: Titan
Lot number: 1234AB

30°C
Expiry date: 31 December 2021

Warnings: Fragile, do not use if

4°C damaged, read instruction for use,
do not resterilise
0123 Steam sterilization

Easy Medical Device Ltd S4M Europe Storage condition: between 4°C
and 30°C
125 Deansgate, Manchester, 59 rue Castellion,
UK M3 2LH 01100 Oyonnax - France Manufacturer: Easy Medical Device

EC REP: S4M Europe

(01)09506000117843(11)141231(17)201 easymedicaldevice.com
UDI-DI: 09506000117843
231(10)1234AB
(01)09506000117843(17)211231(10)1234AB Languages: EN – FR - DE
©Copyright 2021 Easy Medical Device GmbH
 26

Manufacturer

Importer
EAR

End-
User

Distributor

©Copyright 2021 Easy Medical Device GmbH

 27
Importation (Article 13)

► Importers shall indicate on the device or on its

packaging or in a document accompanying the device
their name, registered trade name or registered
trade mark, their registered place of business and
the address at which they can be contacted, so that
their location can be established.
► No obligation to mention the distributor on the label
(Article 14)

©Copyright 2021 Easy Medical Device GmbH

 28
82307-012 Easy
En: Dental implant 3x1,5 mm
Implant
Fr: Implant dentaire 3x1,5 mm
De: Zahnimplantat 3x1,5 mm
1234AB
e n voy
d
En: Material: Titanium Me ress
d ds
Fr: Matière : Titane Ad erlan
h
2021-12-31 De: Material: Titan Net

30°C

4°C

0123
Easy Medical Device Ltd S4M Europe
125 Deansgate, Manchester, 59 rue Castellion,
UK M3 2LH 01100 Oyonnax - France

(01)09506000117843(11)141231(17)201 easymedicaldevice.com
231(10)1234AB
(01)09506000117843(17)211231(10)1234AB
©Copyright 2021 Easy Medical Device GmbH
 29
Relabel and repackaging (Article 16)

► 3.  A distributor or importer that carries out any

of the activities mentioned in points (a) and (b) of
paragraph 2 shall indicate on the device or,
where that is impracticable, on its packaging or
in a document accompanying the device, the
activity carried out together with its name,
registered trade name or registered trade mark,
registered place of business and the address at
which it can be contacted, so that its location
can be established.

©Copyright 2021 Easy Medical Device GmbH

 30
82307-012 Easy
En: Dental implant 3x1,5 mm
Implant
Fr: Implant dentaire 3x1,5 mm
De: Zahnimplantat 3x1,5 mm de n v oy
1234AB Me ress ds
IT: Impianto dentale 3x1,5 mm d
Ad herlan
t
Ne
En: Material: Titanium
2021-12-31 Fr: Matière : Titane
De: Material: Titan
30°C IT: Materiale: titanio

4°C

Ea
Ad sy
0123 Ita dre Med
ly ss ic
al
Easy Medical Device Ltd S4M Europe Ea Lo
125 Deansgate, Manchester, 59 rue Castellion, Ad sy gi
sti
Ita dre Med c
UK M3 2LH 01100 Oyonnax - France ly ss ic
al
Lo
gi
(01)09506000117843(11)141231(17)201 sti
easymedicaldevice.com c
231(10)1234AB
(01)09506000117843(17)211231(10)1234AB
©Copyright 2021 Easy Medical Device GmbH
 31

Questions
Easy Medical Device GmbH
Bernouillstrasse 20 – 4056 Basel
Switzerland

Website: EasyMedicalDevice.com
Email: melazzouzi@easymedicaldevice.com
Tel: +41 79 90 36 836

©Copyright 2021 Easy Medical Device